Contacting Authors to Retrieve Individual Patient Data

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT02569411
• Collaborator: (none)
• Enrollment: 129
• Arms: 2
• Actual Duration (Months): 20.6

Study Details

Study Description

Brief Summary

The objective of this study is to examine the impact of incentivizing authors of RCTs that are eligible for a systematic review and meta-analysis, versus usual contact strategies to obtain original IPD

Condition or Disease	Intervention/Treatment	Phase
Response Rates	Other: Financial Incentive	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial
• Actual Study Start Date: Jun 10, 2016
• Actual Primary Completion Date: Feb 28, 2018
• Actual Study Completion Date: Feb 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No Incentive Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive
Experimental: Incentive Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive.	Other: Financial Incentive; money

Outcome Measures

Primary Outcome Measures

1. Proportion of Authors Who Provided Complete IPD [June 2016 - October 2016]

   We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.

Secondary Outcome Measures

1. Time Taken to Obtain the IPD Between Initial Request and Authors' Provision [June 2016 - October 2016]

   We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.

2. The Completeness of the IPD Received [June 2016 - October 2016]

   We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Corresponding authors of RCTs included in our previous and updated systematic reviews

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Unity Health Toronto

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 15, 2016

More Information

Publications

None provided.

• Responsible Party: Andrea Tricco, Dr., Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02569411
• Other Study ID Numbers: 15-240c
• First Posted: Oct 6, 2015
• Last Update Posted: Jul 1, 2020
• Last Verified: Jun 1, 2020

Study Results

Participant Flow

Recruitment Details	Authors identified in randomized controlled trials that were eligible for inclusion in two systematic review and network meta-analysis papers.
Pre-assignment Detail	Authors whose contact information was unidentifiable were excluded.

Arm/Group Title	No Incentive (Control)	Financial Incentive (Intervention)
Arm/Group Description	Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.	Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
Period Title: Overall Study
STARTED	65	64
COMPLETED	0	0
NOT COMPLETED	65	64

Baseline Characteristics

Arm/Group Title	No Incentive	Incentive	Total
Arm/Group Description	Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive	Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive. Financial Incentive: money	Total of all reporting groups
Overall Participants	0	0	0
Age, Customized () []
Sex/Gender, Customized () []
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	Proportion of Authors Who Provided Complete IPD
Description	We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.
Time Frame	June 2016 - October 2016

Outcome Measure Data

Analysis Population Description

None of the authors in either arm shared individual patient data from their study.

Arm/Group Title	No Incentive (Control)	Financial Incentive (Intervention)
Arm/Group Description	Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.	Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
Measure Participants	65	64
Count of Participants [Participants]	0 NaN	0 NaN

2. Secondary Outcome

Title	Time Taken to Obtain the IPD Between Initial Request and Authors' Provision
Description	We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.
Time Frame	June 2016 - October 2016

Outcome Measure Data

Analysis Population Description

None of the authors in either arm shared individual patient data from their study therefore no data collected for this Outcome Measure.

Arm/Group Title	No Incentive (Control)	Financial Incentive (Intervention)
Arm/Group Description	Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.	Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
Measure Participants	0	0

3. Secondary Outcome

Title	The Completeness of the IPD Received
Description	We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.
Time Frame	June 2016 - October 2016

Outcome Measure Data

Analysis Population Description

None of the authors in either arm shared individual patient data from their study therefore no data collected for this Outcome Measure

Arm/Group Title	No Incentive (Control)	Financial Incentive (Intervention)
Arm/Group Description	Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.	Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
Measure Participants	0	0

Adverse Events

Time Frame	Not applicable. This study is non-clinical and so adverse event data was not collected.
Adverse Event Reporting Description	Not applicable. This study is non-clinical and so adverse event data was not collected.
Arm/Group Title	No Incentive (Control)		Financial Incentive (Intervention)
Arm/Group Description	Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided.		Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study).
All Cause Mortality
	No Incentive (Control)		Financial Incentive (Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	No Incentive (Control)		Financial Incentive (Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	No Incentive (Control)		Financial Incentive (Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.